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May 24, 2022

Pipeline Moves: Corcept’s Phase III pancreatic ductal adenocarcinoma trial termination leads to approval shot dive

The Clinical Trials Arena team also review studies in liver disease, venous leg ulcer, sleep apnoea, and ocular issues.

By Urtė Fultinavičiūtė, William Newton and Adam Zamecnik

In this week’s edition of Pipeline Moves, the team zeroes in on Corcept Therapeutics’s relacorilant in pancreatic ductal adenocarcinoma with news of its Phase III trial termination.

Meanwhile, we look into positive news from early-phase trials in liver disease, venous leg ulcer, and sleep apnoea. Formosa Pharmaceuticals reported positive topline Phase III APP-13007 trial data, with the team pointing to its approval likelihood increase in ocular inflammation and ocular pain.

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Corcept ends pancreatic ductal adenocarcinoma study

Corcept’s relacorilant saw a drop in its Likelihood of Approval (LoA) in pancreatic ductal adenocarcinoma after a Phase III trial was terminated due to observed response rates failing to meet the predefined threshold for continuing the study. The LoA decreased by five points to 2%.

GlobalData evaluated the asset’s PTSR on May 19 after a ClinicalTrials.gov update on May 18. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. 

The Phase III trial (NCT04329949) anticipated to recruit 80 participants but eventually enrolled 43 patients with metastatic pancreatic ductal adenocarcinoma. The study was evaluating the objective response rate (ORR) in patients treated with relacorilant in combination with Abraxane (nab-paclitaxel).

Clinical Trials Arena exclusively reported on February 2021 that key opinion leaders had reservations about data coming from the Phase III trial owing mostly to its design lacking trademarks of a late-phase investigation. The trial should have had a comparator arm with a clinically relevant endpoint like disease-free survival. The Phase III is also primarily designed to demonstrate relacorilant’s mechanism, with the mechanism still having question marks, experts said then.

Positive Phase I liver disease data reported

HepaRegeniX’s HRX-0215 for chronic liver disease saw its Phase Transition Success Rate (PTSR) jump 18 points to 61%. This is after the company reported positive topline Phase I data in a May 12 press release.

The PTSR appraisal occurred on May 16. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. Both LoA and PTSR can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

Germany-based HepaRegeniX enrolled 48 healthy male volunteers in the Phase I single and ascending dose trial (EUDRACT-2021-000193-28). HRX-01215 was well tolerated with no observed drug-related adverse events at any dose level, according to the press release. Vital sign levels and ECG parameters were also stable.

HRX-0215 is a small molecule mitogen-activated protein (MAP) kinase kinase 4 (MKK4) inhibitor. Suppressing MKK4 could increase liver regeneration, including in cases of severe liver disease.

MediWound reports positive Phase II data

MediWound’s EscharEx saw its PTSR in venous leg ulcers leap 16 points to 49%. This was after the company reported that a Phase II trial hit its primary endpoint, in a May 17 company earnings report. The PTSR appraisal occurred on May 19.

The 120-patient Phase II trial (NCT03588130) tested the debridement of venous leg ulcers, measured by a clinical assessor. Patients were randomized 2:2:1 to EscharEx, placebo, and non-surgical standard of care. EscharEx is a topical therapy for chronic wounds, comprised of a concentrate of proteolytic enzymes enriched in bromelain.

Sleep apnoea Phase II trial completes

Incannex Healthcare’s combination of dronabinol and acetazolamide had an increase in its PTSR in obstructive sleep apnoea after a Phase II trial’s recruitment status was marked as completed. The PTSR increased by nine points to 33%. GlobalData evaluated the asset’s PTSR on May 13 after an ANZCTR.org.au update on May 11.

The placebo-controlled Phase II study (ACTRN12620000916943) enrolled 11 adult patients with mild-to-moderate obstructive sleep apnoea. The dose finding trial investigated the combo’s efficacy using the apnoea hypopnea index (AHI).

Formosa makes strides for ocular asset

Formosa’s APP-13007 saw its LoA leap after positive topline data from a Phase III trial. The LoA grew by 16 points in ocular inflammation and by nine points in ocular pain to 43% in both indications. The company reported topline data from the 378-subject study (NCT04739709) in a 12 May press release, with the LoA change taking effect on 16 May.

The placebo-controlled Phase III examined corticosteroid eyedrop APP-13007 in patients who have just undergone routine cataract surgery. The patients were assessed for treatment the following day, marking the first post-operative day (POD1).

In one of the coprimary endpoints, 26.5% of subjects in the APP-13007 group experienced sustained anterior chamber cell (ACC) count of zero, making them inflammation free, from POD8 through to POD15. This is compared with 5.1% in the placebo arm. In another coprimary endpoint, 68% of APP-13007 patients had an ocular pain grade of zero, which is effectively pain free, as early as POD4 through to POD15.

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR. PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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